Trial Review

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

Computerized randomization

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Masking / blinding

Blinded (masking used)

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Who is / are masked / blinded?

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Intervention assignment

Parallel

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Other design features

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Phase

Phase 4

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Type of endpoint(s)

Efficacy

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Statistical methods / analysis

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Recruitment

Recruitment status

Active, not recruiting

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Date of first participant enrolment

Anticipated

1/04/2002

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Actual

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

40

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Accrual to date

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Final

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Recruitment outside Australia

Country [1]31130

Finland

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State/province [1]31130

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Funding & Sponsors

Funding source category [1]2582560

Hospital

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Name [1]2582560

Pirkanmaa Hospital District

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Address [1]2582560

Teiskontie 3533521 TampereFinland

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Country [1]2582560

Finland

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Primary sponsor type

Hospital

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Name

Pirkanmaa Hospital District

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Address

Teiskontie 3533521 TampereFinland

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Country

Finland

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Secondary sponsor category [1]2574210

University

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Name [1]2574210

Medical School, University of Tampere

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Address [1]2574210

Tesikontie33521 TampereFinland

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Country [1]2574210

Finland

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]2602310

Pirkanmaa Hospital Districts Ethics Commitee

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Ethics committee address [1]2602310

Teiskontie 3533521 TampereFinland

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Ethics committee country [1]2602310

Finland

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Date submitted for ethics approval [1]2602310

10/11/2001

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Approval date [1]2602310

11/12/2001

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Ethics approval number [1]2602310

R01165M

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Summary

Brief summary

Diabetic Charcot foot is a rare but devastating foot complication of diabetes mellitus. The resolution of the acute form of Charcot foot needs immobilisation in a cast and total non-weight bearing for at least 12 to 16 weeks. Increased osteoclastic activity is thought to be one of the main pathological feature of the acute Charcot foot. That is why bisphosphonates are widely used in the treatment of acute Charcot process. There are some preliminary studies about the effect of bisphosphonates on the resolution of acute Charcot foot. In this study we investigated the effect of zoledronic acid on the clinical resolution of acute Charcot foot.